X°Port Lung Preservation System; X°Port Lung Preservation Solution— 510(k) K243870

Name: FDA 510(k) clearance K243870
Creator: U.S. Food and Drug Administration
Published: 2025-05-01

Substantially Equivalent

Traferox Technologies, Inc.

FDA 510(k) clearance K243870 for X°Port Lung Preservation System; X°Port Lung Preservation Solution, Substantially Equivalent on 2025-05-01. Applicant: Traferox Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Traferox Technologies, Inc.
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2024-12-17
Decision date: 2025-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

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